TriangleNCT03576131 · OUTCOME
Progression-Free Survival (PFS) According to RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From Day 1 through 8.8 months (corresponding to maximum observed duration)
What was measured
The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and \>= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.
Analysis population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Groups in this outcome
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
| Group | Source count |
|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 10 |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 4 |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 11 |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 7 |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biweekly Regimen (GEN1029 0.1 mg/kg) | 2.5 | Not reported | 0.5 | 3.9 | Not reported |
| Biweekly Regimen (GEN1029 0.2 mg/kg) | 1.4 | Not reported | 0.5 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 0.3 mg/kg) | 2.4 | Not reported | 0.8 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 1.0 mg/kg) | 1.9 | Not reported | 1.2 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 2.0 mg/kg) | 1.2 | Not reported | 1.1 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
| Biweekly Regimen (GEN1029 3.0 mg/kg) | 1.2 | Not reported | 1.0 | NA | Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 3.9
- value
- 2.5
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- NA
- value
- 1.4
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG002
- lower Limit
- 0.8
- upper Limit
- NA
- value
- 2.4
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG003
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.9
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG004
- lower Limit
- 1.1
- upper Limit
- NA
- value
- 1.2
- comment
- Upper limit of 95% confidence interval was not reached due to insufficient events being observed at the time of the analysis.
- group Id
- OG005
- lower Limit
- 1.0
- upper Limit
- NA
- value
- 1.2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and \>= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
- id
- OG000
- title
- Biweekly Regimen (GEN1029 0.1 mg/kg)
- description
- Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG001
- title
- Biweekly Regimen (GEN1029 0.2 mg/kg)
- description
- Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG002
- title
- Biweekly Regimen (GEN1029 0.3 mg/kg)
- description
- Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG003
- title
- Biweekly Regimen (GEN1029 1.0 mg/kg)
- description
- Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG004
- title
- Biweekly Regimen (GEN1029 2.0 mg/kg)
- description
- Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
- id
- OG005
- title
- Biweekly Regimen (GEN1029 3.0 mg/kg)
- param Type
- MEDIAN
- population Description
- Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 8.8 months (corresponding to maximum observed duration)
- title
- Progression-Free Survival (PFS) According to RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice